Cleared Special

K090613 - CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2

K090613 is an FDA 510(k) clearance for CPS AIM SL SLITTABLE INNER CATHETERS, manufactured by St. Jude Medical, Cardiac Rhythm Management Divisi. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 117-day FDA review.

K090613 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular device
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Jul 2009
Decision
117d
Days
Class 2
Risk

K090613 is an FDA 510(k) clearance for the CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by St. Jude Medical, Cardiac Rhythm Management Divisi (Sylmar, US). The FDA issued a Cleared decision on July 1, 2009 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K090613

510(k) Number K090613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2009
Decision Date July 01, 2009
Days to Decision 117 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

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K090613 · CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2
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